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Restrictive Fluid Management for Liver Transplant Patients (REFIL Trial)

Q: Are there any vacancies available for individuals to join this scientific trial?

<p>According to clinicaltrials.gov, this trial is no longer recruiting subjects as its most recent update was on December 8th 2022. However, there are presently 53 other studies looking for volunteers across the country.</p>

N/A

Recruiting

Led By Francois-Martin Carrier, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization up to hospital discharge (ascertained up to end of follow-up at 1 year)

Awards & highlights

REFIL Trial Summary

This trial will test if a low splanchnic blood volume fluid management strategy is feasible in liver transplant patients.

Who is the study for?

The REFIL trial is for adults over 18 years old who need a liver transplant due to end-stage liver disease (ESLD). It's not for those with acute liver failure, cancer without ESLD, retransplantation, amyloid neuropathy, severe kidney failure (GFR < 15), severe anemia (hemoglobin < 80 g/L), or hemodynamic instability.Check my eligibility

What is being tested?

This study compares two fluid management strategies during liver transplantation. One group receives a restrictive strategy with phlebotomy and limited fluids; the other gets a liberal strategy aiming to optimize cardiac output. The goal is to see which method leads to better outcomes.See study design

What are the potential side effects?

Potential side effects may include complications from phlebotomy such as bleeding or infection, fluid imbalance issues like dehydration or overload affecting organ function, and possible cardiovascular stress from managing blood flow and volume.

REFIL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization up to hospital discharge (ascertained up to end of follow-up at 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization up to hospital discharge (ascertained up to end of follow-up at 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up to hospital discharge (ascertained up to end of follow-up at 1 year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

6-month outcome measurement completeness

Adherence

Hospital outcome measurement completeness

+2 more

Secondary outcome measures

7-day AKI (grade 2 or 3)

7-day graft dysfunction

7-day quality of recovery

+12 more

REFIL Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Restrictive group: Low splanchnic blood volume Restrictive fluid management strategyExperimental Treatment2 Interventions

The intervention group is targeted at lowering splanchnic blood volume using a phlebotomy and restricting fluid infusion, individualized to the physiological needs of this population and the distinct LT surgical phases. The strategy will first consist of performing a phlebotomy without fluid replacement at the start of surgery.We will combine it with fluid restriction to prevent excessive fluid administration and its effect on splanchnic blood volume and blood loss, combined with the effect of the phlebotomy, as well as to limit fluid overload, as previously reported. Fluid will be administered to compensate blood loss and treat severe hemodynamic instability.The phlebotomy will be transfused back at the beginning of the reperfusion phase where fluid management will be based on a goal-directed therapy (GDT) using either PPV or SV, as in the control group.

Group II: Liberal group: Optimized cardiac output liberal fluid management strategyActive Control1 Intervention

The control group will receive a liberal intraoperative fluid management strategy optimizing cardiac output throughout the surgery. It will consist of administering 250 mL fluid boluses until SV stops to increase by more than 10% or until PPV is below 12%, a dynamic indicator of fluid responsiveness validated in many surgical populations, including ESLD patients undergoing a LT.This strategy is informed by data from recent clinical trials on benefits of GDT in major surgery, data on strategies used in major surgery, liver resection or LT and our survey on current practice.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Phlebotomy

2016

Completed Phase 3

~1220

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Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,442 Total Patients Enrolled

Canadian Donation and Transplantation Research Program (CDTRP)UNKNOWN

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

129,565 Total Patients Enrolled

Media Library

Low splanchnic blood volume Restrictive fluid management strategy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05647733 — N/A

Liver Transplant Research Study Groups: Restrictive group: Low splanchnic blood volume Restrictive fluid management strategy, Liberal group: Optimized cardiac output liberal fluid management strategy

Liver Transplant Clinical Trial 2023: Low splanchnic blood volume Restrictive fluid management strategy Highlights & Side Effects. Trial Name: NCT05647733 — N/A

Low splanchnic blood volume Restrictive fluid management strategy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05647733 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for individuals to join this scientific trial?

"According to clinicaltrials.gov, this trial is no longer recruiting subjects as its most recent update was on December 8th 2022. However, there are presently 53 other studies looking for volunteers across the country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Restrictive Fluid Management In Liver Transplantation (REFIL)

2023. "Restrictive Fluid Management In Liver Transplantation (REFIL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05647733.

All > Liver Transplant